Pure Food and Drug Act
PURE FOOD AND DRUG ACT
June 30, 1906, was a red-letter day for those who sought progressive reform and consumer protection in the United States. On that date the U.S. government passed the Pure Food and Drug Act, the first in a series of legislation designed to regulate the quality of food and pharmaceutical products. The act banned manufacturers from selling mislabeled products, from adulterating food with unacceptable ingredients, and from misleading consumers with false claims. The passage of the act marked a victory both over certain manufacturers who wished to avoid regulation, as well as some politicians who questioned the constitutionality of the act. Those who fought for consumer protection found that their battle was only just beginning, however, and that effective reform would take place only with a series of acts passed over many years. Government regulation of this kind strongly affected the ways in which foods and drugs were prepared, packaged, labeled, sold, and advertised in the United States.
Prior to 1906 the regulation of food production and commerce fell mainly on the state and local authorities. In the colonial period, the colonies followed the British precedent of establishing laws to ensure standards of decency for such mainstays as bread and butter, while coastal colonies called for mandatory inspection of fish and other seafood. The laws did not extend to drugs, however, and their production remained largely unregulated. State laws scarcely differed from the colonial legislation, which was often loosely enforced. Since food and drug consumption was for the most part safe, there was little reason to push for more stringent regulation.
It was not until the middle of the nineteenth century, with the rise of industrialization and increasing urban populations, that fraudulent practices in the manufacturing of food and drugs became all too common. Food processors often added fillers to extend and cheapen their products: Water thinned out milk, sawdust bulked up flour, and sand stretched sugar. The development of new chemicals that enhanced the color, flavor, and texture of food made it easier for manufacturers to mask their manipulations. Unbeknownst to consumers, dyed and jarred apple scraps and hayseeds sometimes sold as "strawberry jam." With these practices corrupting the marketplace, consumers found it difficult to judge the "truth in labeling" of commodities. Health risks increased, and state laws seemed insufficient to protecting the vulnerable public. The time was ripe for reform.
Harvey Washington Wiley (1844–1930), professor of chemistry at Purdue University and evangelical Christian, led a campaign to stop wayward manufacturers from selling elixirs and bottled medicine which was often no more than alcohol-laden placebo. Wiley was appointed chief chemist of the U.S. Department of Agriculture in 1883. He led a campaign for federal regulation of food production and commerce. He was not alone in his efforts: many upstanding, reputable manufacturers wished for regulations that would outlaw the shady practices of their dishonest competitors. Meanwhile state food and drug officials asked for the federal support necessary to effect such sweeping change. Wiley enlisted scientists to analyze the ingredients in adulterated foods and to conduct tests on harmful preservatives, food colorings, and other chemicals, effectively amassing evidence to present to legislators. Interested as much in the moral as in the medical implications of ingesting tainted foods, the chemist did everything possible to dramatize the issue and to galvanize the public.
Two events gave Wiley's efforts a much-needed boost. The first event was the 1898 "embalmed beef" scandal, which highlighted the quality of food served to soldiers in the Spanish-American War (1898). The second event was the January 1906 publication of Upton Sinclair's The Jungle, a deeply disturbing novel about unsanitary conditions in the Chicago meatpacking industry. Sinclair's best-selling novel—with its grotesque descriptions of rats, filth, and even human body parts that found their way into goods sold as "pickled meats"—was the final straw. President Theodore Roosevelt (1933–1945), who did not always respond to Wiley's sensationalist style of lobbying, reportedly read The Jungle with interest. It is no coincidence that the Pure Food and Drug Act was passed only five months after the book's publication.
The bill was not as thorough as Wiley hoped it would be, but it did represent a triumph for consumer protection in the United States. It forbade the adulteration of food, the addition of harmful ingredients, and the use of erroneous or misleading labels. Interstate and foreign commerce of both food and drugs were to be diligently monitored, and drug manufacturing was to comply with purity standards listed in two authoritative pharmaceutical reference books. Critics of the bill noted the absence of a specific list of purity standards for food manufacturing, which made the law difficult to enforce in certain cases. A Bureau of Chemistry, operating under Wiley, was established to propose a system of enforcement, but the bureau (which was renamed the Food and Drug Administration [FDA] in 1927) often met with opposition from manufacturers and farmers who resisted regulation.
Amendments to the Pure Food and Drug Act— such as one that required manufacturers to list net weight on products' labels (1923) and another that specifically defined the quality standards of canned foods (1930)—helped to plug certain loopholes and ultimately made the bill more effective. The need for certain reforms required new legislation, though, such as the Food, Drug, and Cosmetic Act of 1938, which extended regulatory laws to cover the cosmetics and therapeutic device industries. The FDA gained power to set certain standards and to inflict penalties on those who failed to comply. Ultimately, the Pure Food and Drug Act and subsequent legislation effectively altered the ways in which manufacturing and commerce were conducted in the United States. The events of 1906 set into motion a trend toward consumer protection that persisted throughout the remainder of the twentieth century.
See also: Food Processing, Lever Food Control Act, Pharmaceutical Industry, Regulation
Dictionary of American History. New York: Charles Scribner's Sons, 1976, s.v. "Pure Food and Drug Movement."
Henkel, John. "A Colorful History." FDA Consumer, December 1993.
Hunter, Beatrice Trum. "Detecting Adulterated Food." Consumers' Research Magazine, December 1995.
The Reader's Companion to American History. Boston: Houghton Mifflin Co., 1991, s.v. "Pure Food and Drug Act."
Weisberger, Bernard A. "Doctor Wiley and His Poison Squad." American Heritage, February/March 1996.
food scams, such as apple scraps and hayseeds sold as "strawberry jam," corrupted the marketplace in the nineteenth century united states. the time was ripe for reform.
Pure Food and Drug Act (1906)
Pure Food and Drug Act (1906)
Daniel P. Carpenter
Excerpt from the Pure Food and Drug Act
For preventing the manufacture, sale, or transportation of adulterated or misbranded or poisonous or deleterious foods, drugs, medicines, and liquors, and for regulating traffic therein, and for other purposes.
That the introduction into any State or Territory or the District of Columbia ... of any article of food or drugs which is adulterated or misbranded, within the meaning of this Act, is hereby prohibited?. [Section 2]
That the examinations of specimens of foods and drugs shall be made in the Bureau of Chemistry of the Department of Agriculture, or under the direction and supervision of such Bureau, for the purpose of determining from such examinations whether such articles are adulterated or misbranded within the meaning of this Act.... [Section 4]
It would not stretch matters to say that the Pure Food and Drug Act of 1906 (P.L. 59-384, 34 Stat. 768), also known as the Wiley Act, stands as the most consequential regulatory statute in the history of the United States. The act not only gave unprecedented new regulatory powers to the federal government, it also empowered a bureau that evolved into today's Food and Drug Administration (FDA). The legacy of the 1906 act includes federal regulatory authority over one-quarter of gross domestic product, and includes market gatekeeping power over human and animal drugs, foods and preservatives, medical devices, biologics and vaccines. Other statutes (such as the Interstate Commerce Act of 1887, the Sherman and Clayton antitrust laws, and the Federal Trade Commission Act of 1914) have received more study, but the Pure Food and Drug Act has had the longest-lasting and most widespread economic, political, and institutional impact.
The passage of regulatory legislation came only after two decades of wrangling and congressional opposition to federal regulation of food and drugs. Three political forces converged to force food and drug regulation onto the congressional agenda. First, consumer movements dominated by highly organized women activists put pressure on legislators to satisfy public wishes. The decades-long struggle for a law was actively supported by the General Federation of Women's Clubs (especially Alice Lakey) and the Women's Christian Temperance Union.
A second force was the rise of journalism. In 1905 Upton Sinclair's The Jungle, which exposed practices in the Chicago meat-packing industry, sold 1 million copies in its first year after publication. Nearly as important were the articles of Samuel Collins Adams in Collier's magazine on patent medicines and advertising fraud. These and other articles served to highlight the widespread adulteration of ethical drugs as well as of food.
The most important force behind the act was a single individual, Harvey Washington Wiley, and the agency he led, the Bureau of Chemistry in the U.S. Department of Agriculture (USDA). Wiley assumed leadership of this division of the USDA in 1883 and soon acquired legal and administrative power over the food, patent medicine, and pharmaceutical industries. Wiley experimented with small-scale programs in food regulation, built a multifaceted coalition behind food and drug regulation, and even helped Adams write his Collier's articles. Congress largely followed Wiley's lead, with opponents gradually giving way to Wiley's political machine. The 1906 act stands as one of the most daring demonstrations of bureaucratic autonomy in the history of the United States.
RELATIONSHIP WITH OTHER LAWS
The Pure Food and Drug Act was passed on the same day as the Meat Inspection Act of 1906. This act mandated examination of livestock before slaughter as well as analysis of carcasses, and required ongoing USDA inspection of slaughterhouses and processing plants. The Pure Food and Drug Act and the Meat Inspection Act divided administration of food regulation into two bureaus. The Bureau of Chemistry, headed by Wiley, administered most provisions of the Pure Food and Drug Act. The Bureau of Animal Industry, led by Daniel Salmon, carried out federal meat inspections. This division of administrative oversight persists to this day. The USDA still inspects beef and poultry, whereas the FDA inspects most other foods.
At the time, the Pure Food and Drug Act of 1906 was the most daunting intrusion by federal authorities into interstate commerce. Although other federal agencies could regulate prices and occupational safety, the USDA was now engaged in the regulation of the very manufacture and sale of products, in addition to advertising. Two subsequent laws, the Food, Drug, and Cosmetic Act of 1938 and the 1962 Kefauver-Harris Amendments, strengthened the 1906 act's legacy of empowering the FDA. Today the FDA regulates one-quarter of gross domestic product, and not a week goes by without an FDA action making news headlines. The economic legacy of the act includes strong consumer safeguards, controls on pharmaceutical and medical device markets, regulatory intervention in the process of pharmaceutical development and advertising, and government oversight of food production and marketing.
See also: Federal Food, Drug, and Cosmetic Act; Food Quality Protection Act.
Anderson, Oscar E. The Health of a Nation: Harvey W. Wiley and the Fight for Pure Food. Chicago: University of Chicago Press, 1958.
Bailey, Thomas A. "Congressional Opposition to Pure Food Legislation, 1879–1906." American Journal of Sociology 36 (July 1930): 52–64.
Carpenter, Daniel P. The Forging of Bureaucratic Autonomy: Reputations, Networks and Policy Innovation in Executive Agencies, 1862–1928. Princeton, NJ: Princeton University Press, 2001.
Young, James Harvey. Pure Food: Securing the Pure Food and Drug Act of 1906. Princeton, NJ: Princeton University Press, 1989.